Study Stopped
The funder and the study team have mutually agreed to terminate the study considering the difficulties encountered in recruitment and consequently the impossibility to perform the planned analysis.
An Analysis to Assess Non-adherence in People With Type 2 Diabetes
InvesTigation and Analysis of uRine - Glucose Control in patiEnts With Type 2 Diabetes - TARGET Study
1 other identifier
observational
90
1 country
2
Brief Summary
Non-adherence is defined as: "the extent to which a person's behaviour - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider". Non-adherence in chronic cardiometabolic diseases including diabetes is very common and is often the primary reason for treatment failure. This leads to significant excess costs to the health economy through avoidable investigations, treatment escalations, hospital admissions, and disease complications. Methods to diagnose non-adherence have until recently been poor. We have recently developed an objective and robust chemical adherence test to detect the presence of 160 cardiovascular medications in urine using high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). Chemical adherence testing has not been utilised in people with diabetes, further its relationship with other measures of adherence is unknown. The main aim of this observational study is to compare chemical non-adherence with other commonly used measures of non-adherence in people with diabetes. Chemical testing for non-adherence will be performed using urine provided by 600 patients with poorly controlled diabetes attending primary care recruited over a 15-month period. Participants will also be required to complete a self- reported questionnaire and pharmacy records will be reviewed to ascertain prescription refill rates. The prevalence and metabolic control of non-adherence as diagnosed chemically will be compared with those obtained by pharmacy refill rates and patient self-reported questionnaires. Further, the determinants of non-adherence as ascertained by urine LC-MS/MS analysis will be studied. It is hoped that this innovative study will lead to further larger intervention studies that will change the management of non-adherence in diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2022
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedStudy Start
First participant enrolled
August 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2025
CompletedDecember 16, 2025
December 1, 2024
2.8 years
February 16, 2022
December 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of the agreement between the prevalence rates of non-adherence obtained by LC-MS/MS and the prevalence as diagnosed by (Medication Possession Ratio) MPR ≤0.80
One clinic visit
Secondary Outcomes (3)
Measurement of the agreement between the prevalence rates of non-adherence diagnosed by LC-MS/MS and that diagnosed by Hill-Bone Medication Adherence Scale (HB-MAS) <36
One clinic visit
Measurement of the difference between metabolic control as assessed by HbA1c, LDL-cholesterol and clinic BP and the three methods to diagnose non-adherence
One clinic visit
Determination of significant predictors of non-adherence as diagnosed by urine LC-MS/MS
One clinic visit
Interventions
Urine/blood samples will be collected from participants, also they will be asked to complete a medication adherence questionnaire, medication records will also be examined to determine the pharmacy refill rate.
Eligibility Criteria
Male and female (non-pregnant nor breast feeding) subjects with uncontrolled diabetes attending their routine Diabetes review that are capable of giving informed consent, who are above 18 years of age, and have been prescribed at least one oral hypoglycaemic agent and one other medication for cardiovascular disease.
You may qualify if:
- Aged 18 years and over
- Confirmed diagnosis of type 2 diabetes
- People with at least one HbA1c ≥ 7.5% (59mmol/mol) measured in the last 6 months
- Patients on at least one OHA and one other oral cardiovascular medication for blood pressure, diabetes or lipid lowering therapy
- Patients able to understand written and verbal English
You may not qualify if:
- Type 1 diabetes
- Age less than 18 years
- Patients unable to give informed consent
- Pregnant or planning pregnancy
- Terminally ill
- Patients on simvastatin and or aspirin if they are the only other medication for cardiovascular disease besides the OHAs that the patient is prescribed.
- Patients on insulin or GLP-1 analogues if they are the only other medication for cardiovascular disease that the patient is prescribed.
- Major medical or psychiatric illness
- Patients unable to understand written and verbal English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Banks Surgery
Loughborough, LE12 7RD, United Kingdom
The Cottage Surgery
Loughborough, LE12 8RY, United Kingdom
Biospecimen
Urine \& blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2022
First Posted
February 25, 2022
Study Start
August 30, 2022
Primary Completion
June 17, 2025
Study Completion
June 17, 2025
Last Updated
December 16, 2025
Record last verified: 2024-12